A Clonmel drug startup is aiming to improve treatment for cancer patients, writes Trish Dromey.
An oncology drug which is easier to administer to women suffering from ovarian cancer than those currently available on the market is the first of a number of innovative drugs under development at Shorla Pharma in Clonmel, Co Tipperary.
The two-year-old pharmaceutical startup specialises in developing oncology drugs for rare forms of cancer in women and children.
The company is also working on an oral product for paediatric cancer which will be easier for children to swallow than the hard capsules currently used.
Since the setting up of Shorla Pharma in January 2018, the company has raised €2m which has included funding from its founders Sharon Cunningham and Orlaith Ryan as well as from private investment.
“Our goal is to create an innovative pipeline of oncology product for unmet needs”, said founders Sharon Cunningham and Orlaith Ryan, who plan to launch their first product for ovarian cancer on the US market in 2021 and to develop global sales for a range of specialist oncology products.
The two women worked together in Eirgen Pharma in Clonmel for seven years. Ms Ryan was in charge of regulatory affairs and Ms Cunningham was head of finance.
“When Eirgen was taken over by a US multinational in 2015, we decided to do something on our own,” said Ms Cunningham.
They spent two years drawing up a business plan and exploring product ideas before starting Shorla.
“We originally had ideas for 15 products but narrowed this down to four,” said Ms Ryan.
She said they consulted with oncologists and opinion leaders and found these four products were ones which could be commercialised and brought to market relatively quickly.
“Our strategy has been to innovate to solve problems by creating new ways to use established active ingredients,” said Ms Ryan.
Using their own funding to start, they received a priming grant from Clonmel Local Enterprise Office and assistance to establish a website after attending an Investment Summit in Washington, USA, in 2018.
“We initiated the formulation development of our first product in the third quarter of last year via a European laboratory,” she says.
Ms Ryan said they used contract labs to implement and perform testing in order to come up with a working formulation for their novel product ideas.
The €2m funding has been used to contract the services of specialists in the fields of pharmaceutical R&D, regulatory compliance and global product commercialisation as needed.
In June, the company held a development meeting with the Food and Drug Administration (FDA) in the US which is their initial target market.
The founders said the FDA agreed with their clinical and regulatory strategy for this product, which means the company can forge ahead with plans to launch on the US market in 2021.
Shorla has submitted the development strategy for its second product, for paediatric cancer, to the FDA, and has been granted a meeting later this month.
With commercial scale-up of these products imminent, the company is in negotiations for a further multi-million euro fundraising round that is expected to close by the end of the year.
Shorla plans to start recruiting at the end of the year developing a pipeline of products. “We expect to employ a team of 14 highly skilled people in Clonmel by 2021”, said Ms Cunningham, adding that they will start with the US market and then develop global sales.
The winner of the Tipperary round of the Ireland’s Best Young Entrepreneur Competition, Shorla is now through to the national finals of the competition, which is set to take place on September 15.